FDA Inspection
Patheon Puerto Rico, Inc.Patheon Puerto Rico, Inc. – FDA Inspection, Aug 11, 2014
Record Details
This FDA Inspection record concerns Patheon Puerto Rico, Inc., with an inspection on August 11, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Patheon Puerto Rico, Inc.
- Inspection Date
- August 11, 2014
- Product Type
- Drugs
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ID · 41582db4-1a07-4c42-833f-08084d665311
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891131
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Patheon Puerto Rico, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2026 | Not classified | San Juan District Office | Drug Quality Assurance |
| July 12, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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